Determination of the Composition of Substances Migrating from Plugs Based on Bromo-Butyl Rubber into Infusion and Injection Preparations

摘要

The results of experimental studies of the composition of individual substances migrating from medical rubber plugs produced both in Russia and abroad based on technical bromobutyl rubber are presented. The quantitative content of volatile organic compounds related to species impurities of gasoline was determined by gas chromatography from a standard glass bottle sealed with a sterile stopper based on bromobutyl rubber. The method of atomic emission spectroscopy was used to determine (indirect) the presence of organometallic, organosulfur and metal-inorganic compounds that did not pass through chromatographic columns, and the presence of organometallic, organosulfur and metal-inorganic compounds was determined by the content of metal and non-metal cations. The results of mass spectral studies of extracts of aqueous extracts from plugs based on bromobutyl rubber showed that they contain impurities of bromo-alkanes and bromo-arenes, which are direct-acting carcinogens.